Ginu Bibin
Pharmacovigilance Publishing and Distribution Manager @ Opella | Manage eCTD submissions in Veeva RIM & Calyx RIM, Oversight Management, Driving Global Safety and Regulatory Compliance
- Role
- Manager at Opella
- Location
- Thiruvananthapuram, KL, IN
- LinkedIn followers
- 500 followers
About Ginu Bibin
As a Regulatory Affairs Manager at Parexel with over 14 years of experience, the focus is on optimizing global regulatory submissions and compliance strategies. Proficient in quality management, transition planning, and lifecycle management, work emphasizes collaboration with cross-functional teams to streamline regulatory operations and mitigate risks. Parexel\'s initiatives leverage Lean Six Sigma and Agile methodologies to enhance operational efficiency and ensure alignment with global standards. By addressing root cause analysis and driving CAPA improvements, contributions have strengthened compliance frameworks and supported successful product transitions in the life sciences sector.
Experience
Manager
Aug 2025 — Present · Hyderabad, IN
Pharmacovigilance product coordination, Global Safety report publishing, Oversight management
Education
Cranfield University
Master of Science - MS, Clinical Research Coordinator
University of Mumbai
Msc clinical research, clinical research
2009 — 2011
Cranfield University
Master's degree, Clinical Research
2009 — 2011
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